Kornimate/medical-research-clean huggingface dataset:
multilevel intervention for precision oncology

Conditions: Advanced Cancers of the Prostate; Cancers of the Lung

Summary: the investigators are rolling out a 3 level intervention designed to improve the use of precision oncology at 8 va medical centers. the 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their precision oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of precision oncology tests.

background: precision oncology (po), the use of molecular testing to identify tumor specific abnormalities which facilitate targeted therapy, is proven to extend lives and improve quality of life for patients with cancer. extensive study, however, documents that up to 50% of patients in the va, especially those with adverse social determinants of health (older age, rural), do not receive guideline recommended po. methodology: building on the investigators' previous analyses, and the theoretical domains framework, the investigators designed a mixed-methods type i hybrid effectiveness-implementation study of a multilevel intervention (mli) to improve the use of po. the mli will be instituted for veterans with advanced cancers of the colon, lung, and prostate, as well as providers at 8 sites, chosen to represent diversity at the level of rurality, geographic region, cancer volume, and mode of delivery (virtual/in-person). the patient intervention is a 5-minute educational module accessible by qr code. the provider intervention is a 45-minute academic detailing session, as well as individualized audit and feedback on practice patterns. the facility level intervention is a previously piloted integration of po ordering, interdepartmental communication, and results return into the primary electronic medical record via a consult function. the primary efficacy outcome is the rate of molecular testing/eligible veterans. validated survey measures will be used for stakeholder engagement. the process evaluation employs a mixed methods approach based in the re-aim framework, which includes quantitative analyses of collected data, and interviews of patients and providers. the statistical design is a randomized stepped-wedge trial over 3 years which retains control data from across all sites.

Eligibility criteria:
inclusion criteria: * patients in the va with cancer of the lung or prostate who are seen in the oncology clinic exclusion criteria: * cancer that did not originate in the prostate or the lung
investigation of the effects of proprioceptive neuromuscular facilitation techniques and core stabilization exercises on physical and functional parameters in adolescents with idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: adolescent idiopathic scoliosis (ais) is a prevalent three-dimensional torsional disorder, primarily affecting adolescents during puberty. characterized by a lateral deviation of the spine greater than 10°, ais can lead to physical and psychological issues, including back pain, cosmetic deformity, and reduced quality of life. this study aims to compare the effects of proprioceptive neuromuscular facilitation (pnf) techniques and core stabilization exercises on physical and functional parameters in adolescents with idiopathic scoliosis. this randomized controlled trial was conducted with 52 adolescents aged 10-18 years, diagnosed with ais (cobb angle of 10-30°). participants were randomly assigned to either the pnf group or the core stabilization group. both groups underwent a 10-week supervised exercise program, supplemented by a home exercise regimen. primary outcomes included changes in the cobb angle and angle of trunk rotation (atr). secondary outcomes assessed quality of life (srs-22), perceived trunk appearance (wrvas), and physical function (6mwt and sts).

adolescent idiopathic scoliosis (ais) is a prevalent three-dimensional torsional disorder, primarily affecting adolescents during puberty. characterized by a lateral deviation of the spine greater than 10°, ais can lead to physical and psychological issues, including back pain, cosmetic deformity, and reduced quality of life. this study aims to compare the effects of proprioceptive neuromuscular facilitation (pnf) techniques and core stabilization exercises on physical and functional parameters in adolescents with idiopathic scoliosis. this randomized controlled trial was conducted with 52 adolescents aged 10-18 years, diagnosed with ais (cobb angle of 10-30°). participants were randomly assigned to either the pnf group or the core stabilization group. both groups underwent a 10-week supervised exercise program, supplemented by a home exercise regimen. primary outcomes included changes in the cobb angle and angle of trunk rotation (atr). secondary outcomes assessed quality of life (srs-22), perceived trunk appearance (wrvas), and physical function (6mwt and sts).

Eligibility criteria:
inclusion criteria: 1. aged between 10 and 18 years old, 2. first-time diagnosis of ais, 3. risser sign of 0-3 and a cobb angle of 10-30°, 4. sanders classification of 0-6, 5. lenke curve type 1 or type 1a, 6. volunteered to participate in the study. exclusion criteria: 1. the presence of other types of scoliosis (e.g., congenital or neuromuscular scoliosis), 2. a history of spinal surgery, 3. use of a brace, 4. contraindications for exercise (e.g., cardiovascular or respiratory disorders), 5. previous ais treatment, 6. rheumatological diseases, and/or other neuromuscular problems.
investigation of a-ecm for the correction of soft tissue defects

Conditions: Disorder of Soft Tissue of Body Wall Region

Summary: soft tissue injury leads to significant deformity in size, shape and body contour. adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects. current autologous fat transfer techniques, however, have a number of limitations including significant donor site morbidity, unpredictable resorption, and the potential for requiring revision. thus, an "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction. extracellular matrix (ecm)-based biomaterials have the potential to be a non-immunogenic biological scaffold for adipose tissue engineering for repair of soft tissue defects. our collaborators have recently generated a novel tissue-derived material to improve soft tissue reconstruction. the final, processed adipose tissue does not contain cellular components, yet retains the native architecture and bioactivity of the original adipose tissue. the tissue is then further processed into particles to create an injectable implant. in preclinical models, we have demonstrated that human adipose tissue can be decellularized by mechanical processing with preservation of matrix ultrastructure. histologic analysis two-weeks after implantation into rats showed minimal inflammatory reaction and good tissue integration of the decellularized, dilipidized, adipose derived-ecm. the goal of the study is to 1) evaluate the safety and compatibility of the soft tissue implant, and 2) determine the efficacy of this ecm replacement in soft tissue injuries after 6 weeks. specifically, the volume of the soft tissue defect will be determined before implantation and at multiple time points over the following 6 weeks. we hypothesize that the decellularized adipose ecm will retain at least 50% volume and surface area after 6 weeks. if our results are promising, decellularized adipose derived-ecm may be a viable alternative to autologous tissue transplantation for correction of soft tissue deformity.


Eligibility criteria:
inclusion criteria: * men and women, ages 20-50, with previous congenital or acquired soft tissue deformities of the body or face that are willing to have photographs taken may join this study exclusion criteria: * pregnant women, patients with known immunocompromise or wound healing disorders

Keywords: scar soft tissue defect
feno and cytokines in respiratory syncytial virus (rsv) and non rsv bronchiolitis in relation to future asthma

Conditions: Acute Bronchiolitis

Summary: the purpose of this study is to determine fractional exhaled nitric-oxide (feno)levels and blood cytokines during acute bronchiolitis, and to seek for correlation between these markers and future development of asthma.


Eligibility criteria:
inclusion criteria: * first episode of shortness of breath * children in ages 2 weeks to 2 years exclusion criteria: * any chronic disease * congenital anomalies

Keywords: bronchiolitis feno asthma wheezing, rsv
a study of safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous (sc) administered alirocumab in healthy chinese subjects

Conditions: Hypercholesterolemia

Summary: primary objective: to assess the safety and tolerability of ascending single sc doses of alirocumab in chinese healthy subjects. secondary objectives: * to assess the pharmacokinetic profile of a single sc dose of alirocumab. * to assess the pharmacodynamic effect of a single sc dose of alirocumab on low-density lipoprotein cholesterol (ldl-c) and other lipid parameters. * to assess the immunogenicity of a single sc dose of alirocumab.

ascending dose design includes 3 dose levels. tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. total duration of the study per subject is approximately 15 weeks (including screening period).

Eligibility criteria:
inclusion criteria: * healthy male or female subjects. * aged 18 to 45 years old. * low-density lipoprotein cholesterol \>100 mg/dl (2.59 mmol/l). exclusion criteria: * subjects with any history or presence of clinically relevant illness. * serum triglycerides \>200 mg/dl (2.26 mmol/l) measured after at least 10 hour fasting. * use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. use of probucol within 8 weeks prior to screening. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
long-term cognitive decline after coronary artery bypass grafting: is off-pump surgery beneficial?

Conditions: Coronary Artery Disease; Cardiopulmonary Bypass; Cognition Disorders

Summary: coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of the heart lung machine. we hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine. the objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome, five years after surgery.

background: coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of cardiopulmonary bypass (cpb). a large recent study by newman et al demonstrated that the incidence of cognitive decline was 24% at six months after surgery, but it increased to 42% at five years. in the recently conducted octopus randomized trial, cognitive decline at three months after surgery was present in 29% of the patients operated with cpb. in the patients operated without cpb, the incidence was 21%, i.e. only slightly better. hypothesis: improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery. study objectives: the objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome, five years after surgery. methods: the 281 participants of the octopus study, who were operated on between march 1998 and august 2000 and randomized to off-pump or on-pump coronary bypass surgery, will be invited for an additional assessment of their cognitive and clinical status and quality of life, five years after surgery. patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status. clinical status will be assessed by an interview. questionnaires will be used to measure quality of life.

Eligibility criteria:
inclusion criteria: * indication for (first-time) coronary artery bypass surgery * off-pump cabg considered technically possible exclusion criteria: * concomitant valve surgery * unable to complete neuropsychological testing * life expectancy less than 1 year

Keywords: coronary artery disease cardiopulmonary bypass cognition disorders
mobile individual atrial fibrillation management program

Conditions: Atrial Fibrillation (AF)

Summary: the aim of the study is to develop a mobile individual atrial fibrillation management (m-bafy) program and to evaluate the effects of the program on symptom severity, medication compliance, self-care agency and quality of life. the main questions that the study aims to answer are as follows; * is the m-bafy program effective in symptom control? * is the m-bafy program effective in increasing medication compliance? * is the m-bafy program effective in improving self-care agency? * is the m-bafy program effective in improving quality of life? in order to measure whether m-bafy is effective, the researchers will download this application to one group's phones, and the other group will not download the application. participants; * use this application for 3 months * patients in the intervention group use the application at least once every two weeks. * fill in the symptom diary in the application. * clinical interviews are called for the first interview, at the end of the 1st month and at the end of the 3rd month.

the research sample was divided into two groups, the intervention and control groups, using the simple randomization method. the m-bafy program prepared for the intervention group will be downloaded to their phones and asked to use it for three months. a unique username and password will be created for each patient. patients' records and navigation between tabs will be tracked via the firebase system. motivational messages and feedback will be given to patients. patients will be informed that they will be provided with consultancy services within the scope of the program content throughout the research. the standard program of the clinic will be applied to the patients in the control group. no intervention will be made by the researcher. follow-up data will be collected by the researcher at the end of the 1st and 3rd months using the tools in the data collection form.

Eligibility criteria:
inclusion criteria: * being 18 years old and above * having an af diagnosis * being literate * being able to understand and speak turkish * being able to use a smartphone * being willing to participate in the study exclusion criteria: * hearing and speech problems * cardiac surgery \< 3 months before the interview date * presence of psychiatric disease * no data entry for at least 2 weeks

Keywords: atrial fibrillation mobile health nursing care
an observational study on the health related quality of life in patients with chronic lymphocytic leukaemia

Conditions: Lymphocytic Leukemia, Chronic

Summary: this observational study will assess the health related quality of life (hqrl) profiles of patients with chronic lymphocytic leukaemia. using health assessment questionnaires, data will be collected from patients currently receiving therapy and from those who have finished therapy and have undergone an assessment of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with chronic lymphocytic leukaemia * patients receiving 1st line therapy * patients receiving 2nd line therapy. this will include patients who previously have responded well to 1st line therapy (relapse was \>12 months after finishing the 1st line therapy) and are receiving the same therapy again * within the past three months, patients whose treatment has been stopped after 2-3 cycles of 1st or 2nd line therapy and who have not received any further therapies * patients receiving their 3rd, 4th, 5th or 6th cycle of 1st or 2nd line therapy * patients who have completed therapy, are considered stable and are between 3-12 months post therapy * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * clinically significant disorder (other than chronic lymphocytic leukaemia and chronic lymphocytic comorbidities) or any other condition, including alcohol or drug abuse, which may interfere with study participation or affect study conclusions * mental disability or significant mental illness, legal incapacity or limited legal capacity * current high degree of comorbid burden that might affect the accuracy of the quality of life data
actigraphy sleep parameters in obstructive sleep apnea patient's

Conditions: Obstructive Sleep Apnea

Summary: those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. the outcomes that will be analyzed are: time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off


Eligibility criteria:
inclusion criteria: * patient's with osa suspicion undergoing a psg in the sleep unit exclusion criteria: * neurologic disorders * severe comorbidities * other sleep disorders, such as insomnia * no informed consent

Keywords: actigraphy polysomnography obstructive sleep apnea
lxr and oocyte meiosis resumption

Conditions: Female Infertility

Summary: previous studies in animal model showed clearly that lipid homeostasis influence oocyte meiosis resumption. however liver x receptors pathway has never been investigated in human ovocyte

in mice deficient of liver x receptor (lxr) genes, the oocytes are unable to resume meiosis. oxysterols are molecules derived from the cholesterol synthesis pathway. they are ligands of the liver x receptors (lxrs). in human, the lxr signalling pathway has never been investigated in this process. the investigator propose to analyse in granulosa cells surrounding ovocyte the expression of lxr, their target genes and the enzymes involved in oxysterols synthesis. these granulosa cells are normally retrieved and destroyed 18 hours after sperm insemination of oocytes in a in vitro fertilization program. the oocyte meiosis resumption will be considered as positive (granulosa cell positive, gc+) if a zygote is observed 18 hours after sperm insemination and negative (granulosa cell negative, gc-) if none zygote appears. moreover the investigator will analyse the quality of embryo development during 5 days after zygote is formed (normal process of in vitro fertilization) . the both populations of granulosa cells (gc+ and gc-) will be compared. the measurements of liver x receptor genes and the enzymes involved in oxysterols pathways xill be performed by reverse transcription-polymerase chain reaction. the accumulation of lipid in granulosa cells will be measures by oil red staining. by this sudy the investigator will probably find new biological markers of resumption meiosis for women enrolled in in vitro fertilization programm. moreover, data will help to better understand the physiopathology of oocyte meiosis failures.

Eligibility criteria:
inclusion criteria: * woman aged less 37 years * included in a ivf program * tubal infertility * ovarian stimulation with recombinant fsh * induced ovulation by recombinant chorionic gonaotrophin exclusion criteria: * dysovulation * male infertility * ovarian insuficiency
artificial intelligence and bone tomoscintigraphies achieved with czt camera

Conditions: Bone Lesion

Summary: this study aimed to determine whether the whole-body bone single photon emission computed tomography (spect) recording times of around 10 minutes, routinely provided by a high-sensitivity 360 degrees cadmium and zinc telluride (czt) camera, can be further reduced by a deep learning noise reduction (dlnr) algorithm.

this study aimed to determine the extent to which fast whole-body bone-spect recording times, routinely obtained with a high-sensitivity 360 degrees czt-camera and rather low injected activities, can be further reduced using the dlnr algorithm.

Eligibility criteria:
inclusion criteria: * patients referred to fast whole-body bone single photon emission tomography for detection or follow-up of bone metastasis
reducing the risk of cognitive decline ad dementia in patients with subjective cognitive decline through an immersive virtual reality and telemedicine-based multi-component intervention: the scd-recoded study

Conditions: Subjective Cognitive Decline

Summary: older adults with subjective cognitive decline (scd) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. to date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. in this framework, the aim of this project is to evaluate the efficacy of an immersive virtual reality (ivr) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., scd). for this purpose, a randomized, double-blinded controlled trial (rct) will be conducted on seventy-five eligible individuals with scd, who will be randomly assigned to one of three conditions: (a) multi-component intervention (mc-i), including scd-tailored cognitive ivr training plus a health and lifestyle education program, (b) cognitive-only intervention (co-i), including the scd-tailored cognitive ivr training plus an active control for the education program, and (c) active control intervention (ac-i) for both cognitive training and education program. intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). users' compliance with ivr and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.


Eligibility criteria:
inclusion criteria: * self-perceived decline in cognition compared to five years ago * lack of objective cognitive impairment. exclusion criteria: * clinically significant depression and anxiety; * psychiatric disorders; * unstable medical conditions. * severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution * dizziness or epilepsy history;

Keywords: subjective cognitive decline multi-component training non-pharmacological intervention virtual reality telemedicine